Completed

A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+9

+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2006
See protocol details

Summary

Principal SponsorGynecologic Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2006Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma that failed higher priority treatment protocols. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 1-3.4 years.

Official TitleA Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma 
NCT00087100
Principal SponsorGynecologic Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
51 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Endometrial Neoplasms
Female Urogenital Diseases
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed endometrial adenocarcinoma * Persistent or recurrent disease * Refractory to curative or standard therapy * Measurable disease * At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan * Tumors within a previously irradiated field are considered non-target lesions unless progression is documented or biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy * Must have received 1 prior chemotherapy regimen for endometrial cancer * Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age * Any age Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL Hepatic * AST and ALT ≤ 3 times upper limit of normal (ULN)\* * Alkaline phosphatase ≤ 3 times ULN\* * Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 5 times ULN if liver metastases are present Renal * Creatinine clearance ≥ 45 mL/min Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation * Neuropathy (sensory and motor) ≤ grade 1 * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior biologic or immunologic agents for the malignant tumor * One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: * Monoclonal antibodies * Cytokines * Small-molecule inhibitors of signal transduction * At least 24 hours since prior growth factors * No concurrent routine colony-stimulating factors Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy * No prior pemetrexed disodium Endocrine therapy * At least 1 week since prior hormonal therapy directed at the malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy and recovered * No prior radiotherapy to ≥ 25% of bone marrow Surgery * Recovered from prior surgery Other * At least 3 weeks since other prior therapy directed at the malignant tumor * No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration * Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed * No prior therapy that would contraindicate study participation


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 23 locations
Suspended
Jonsson Comprehensive Cancer Center at UCLALos Angeles, United StatesSee the location
Suspended
Hinsdale Hematology Oncology AssociatesHinsdale, United States
Suspended
CCOP - Carle Cancer CenterUrbana, United States
Suspended
St. Vincent Indianapolis HospitalIndianapolis, United States

Completed23 Study Centers
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